Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
Study Overview
Brief Summary
Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization.
There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age - 40-80 years
- •HPIN on prostate biopsy specimens
- •PSA below 20ng/ml
- •No hormone therapy or radiation in pelvic region
- •No previous treatment with 5alfa reductase inhibitors
- •Signed Subject Information and Informed Subject Consent Form.
Exclusion Criteria
- •Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
Arms & Interventions
dutasteride
treatment group
Intervention: dutasteride (Drug)
dutasteride
treatment group
Intervention: prostate biopsy (Procedure)
watchful waiting strategy
Intervention: prostate biopsy (Procedure)
Outcomes
Primary Outcomes
rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
Time Frame: 6, 12, 24, and 36 months
Secondary Outcomes
- effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).(6, 12, 24, and 36 months)
Investigators
Stasys Auskalnis
doctor
Lithuanian University of Health Sciences